MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD D.44 H.14MM; HUMERAL HEADS (COCRMO) - DIA.44MM H.14

Model Number 1321.09.441

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Muscle/Tendon Damage (4532)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #1817700, #1910149, #1912237 and #1906362, no pre-existing anomaly was detected on all the components manufactured with these lot #s.We will submit a final mdr once the investigation will be completed.

Event Description

Revision surgery due to rotator cuff failure performed on (b)(6) 2020.The surgeon believes he placed the primary too high.The components: smr humeral head d.44 h.14mm (product code 1321.09.441, lot# 1817700 - ster.1900087).Smr ecc.Adaptor taper standard (product code 1330.15.274, lot# 1910149 - ster.1900298).Smr finned humeral body (product code 1350.15.110, lot# 1912237 - ster.1900318).Were explanted.The surgeon removed also the poly part of the tt hybrid cem.Glenoid (product code 1379.59.100, lot# 1906362 - ster.1900156) from the peg but experienced some difficulties, increasing the surgical time of about one hour.This intra-op issue was registered as (b)(4) and reported to the fda as mfr 3008021110-2020-00078.Previous surgery performed on (b)(6) 2019.Patient is a male, (b)(6) years old.Event happened in (b)(6).

Event Description

Shoulder revision surgery due to rotator cuff failure performed on (b)(6) 2020.During this surgery, the smr anatomic implant was converted to reverse configuration.The previous surgery was performed on (b)(6) 2019.According to the information received, "the surgeon believes he placed the primary too high".The following components were explanted on (b)(6) 2020: smr humeral head d.44 h.14mm (product code: 1321.09.441, lot: n.1817700 - ster.1900087).Smr ecc.Adaptor taper standard (product code: 1330.15.274, lot: n.1910149 - ster.1900298).Smr finned humeral body (product code: 1350.15.110, lot: n.1912237 - ster.1900318).Moreover, the surgeon removed the poly part of the tt hybrid cem.Glenoid (product code: 1379.59.100, lot: n.1906362 - ster.1900156) from the peg but experienced some difficulties, increasing the surgical time of about one hour.This intra-operative issue was registered as complaint: (b)(4) and reported to fda (ref: 3008021110-2020-00078).Patient is male, 62 years old.This event occurred in the united kingdom.

Manufacturer Narrative

The device history records of the explanted components were checked with the following results: no pre-existing anomaly was detected on the 18 smr humeral heads d.44 h.14mm, product code: 1321.09.441 that belongs to lot: n.1817700 - ster.1900087.No pre-existing anomaly was detected on the 51 smr ecc.Adaptor tapers standard, product code: 1330.15.274 that belong to lot: n.1910149 - ster.1900298.No pre-existing anomaly was detected on the 60 smr finned humeral bodies, product code: 1350.15.110 that belong to lot: n.1912237 - ster.1900318.No pre-existing anomaly was detected on the 18 tt hybrid cem.Glenoids, product code: 1379.59.100 that belong to lot: n.1906362 - ster.1900156.No other similar complaints were registered on these lot numbers.Very few information is available on this case, specifically, even if repeatedly asked to the complaint source, the following information was never received: x-rays.Additional details on the suboptimal positioning reported.Additional information on the patient such as bmi, activity level, clinical conditions.Furthermore, the explanted components were not available to be returned to limacorporate for specific analyses.Without the possibility to analyze the explants and/or the x-rays, we cannot determine with certainty the cause of this revision surgery.However: the check of the production documents did not highlight any pre-existing anomaly on the involved lot numbers, thus we can state that the involved components had been manufactured up to drawing specifications, based on the information received, the surgeon responsible commented on the possibility of a suboptimal components positioning as contributory factor.In conclusion, this event is classified as not product-related.No corrective action is needed following this complaint.Limacorporate will keep monitoring the market to promptly detect any further similar event.Pms data: based on limacorporate pms data, the estimated revision rate of smr anatomic total due to cuff failure is about (b)(4).More than 85% of these cases were classified as patient-related.

• Brand Name: SMR HUMERAL HEAD D.44 H.14MM
• Type of Device: HUMERAL HEADS (COCRMO) - DIA.44MM H.14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 10618478
• MDR Text Key: 209638565
• Report Number: 3008021110-2020-00079
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K161476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1321.09.441
• Device Lot Number: 1817700
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention